Alumis reports 54% PASI 100 skin clearance at 48 weeks in envudeucitinib long-term data
Alumis reported topline results from the ONWARD3 long-term extension study of envudeucitinib in plaque psoriasis, with 54% of patients reaching complete skin clearance (PASI 100) after 48 weeks of continuous treatment. The company said safety was consistent with prior data and that it remains on track to submit a New Drug Application to the FDA in the fourth quarter of 2026, which is the next key regulatory step for shareholders to watch.
Key points
- 54% of patients achieved PASI 100 and 75% achieved PASI 90 in the ONWARD3 NRI analysis of 773 patients treated for up to 48 weeks
- An integrated NRI analysis across ONWARD1/2 and ONWARD3 of 890 patients showed 47% PASI 100 and 66% PASI 90 after 48 weeks
- No new safety signals were observed, and the safety profile was consistent with ONWARD1/2
- NDA submission planned for 4Q 2026; topline data from the LUMUS Phase 2b lupus trial expected in Q3 2026
The filing
Written by AI on Nov 9, 2026, 11:44 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on August 10, 2026.
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.